Policies, Product Choices, and Personnel Competency

By Lou Diorio, RPh  

As the pharmacy community waits for the imminent release of updates to USP <797>, many are speculating how these changes will impact compounding practice, while others have chosen to ignore the discussion altogether, justifying their position by claiming there is a lack of sufficient evidence-based data to support the notion that changes to cleanrooms and compounding practices are needed at all.

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As the pharmacy community waits for the imminent release of updates to USP <797>, many are speculating how these changes will impact compounding practice, while others have chosen to ignore the discussion altogether, justifying their position by claiming there is a lack of sufficient evidence-based data to support the notion that changes to cleanrooms and compounding practices are needed at all. However, the fact remains that USP <797> represents a best practice for the compounding of sterile preparations. Even in the absence of specific legal requirements, pharmacists should assess the chapter’s applicability to their practice and change their procedures as they deem necessary. This exercise can protect both the pharmacist and the patient, and can assist pharmacists in maintaining compliance with current standards.

I prefer to learn from the lessons of history and not repeat previous disasters. In the late 19th century, Joseph Lister and other luminaries of the age suggested that the presence of bacteria could cause infection. The scientific basis for cleanrooms was developed out of the effort to minimize or eliminate the presence of bacteria, with the goal of reducing the incidence of infections in hospitals. Intense focus was placed on hospital operating rooms to achieve this goal. During this time, the discovery was made that the incidence of airborne infections could be greatly reduced by providing proper ventilation of critical areas.

During the ‘60s, a team of scientists developed the concept of the modern cleanroom. These advances in technology brought with them a need to quantify the level of performance of these controls, and in 1963, the first national standard for air cleanliness was developed, Federal Standard 209A. In 1992, following several revisions to the federal standard, the International Organization for Standardization (ISO) developed an international standard, and in 2001 the United States Government retired FS 209E and replaced it with ISO-14664-1.¹

Why Is Cleaning Necessary?
So why is there all this confusion over technology and standards that were developed and have been proven over the last half century? The answer lies within the fact that “cleanrooms” really do not clean anything. Cleanrooms are controlled environments in which critical operating standards can be maintained, predominantly by the compounding complex’s primary and secondary engineering controls. However, there is no substitute for the vigilance of compounding personnel in keeping these critical environments clean. Even if a cleanroom’s engineering controls are sufficient and functioning properly, and even if strict garbing, hand washing, and other gowning procedures are in place, consistent and effective cleaning and disinfection procedures are still needed to continually decrease bioburden (i.e., particles) within the facility. Bioburden serves as a transport medium for viable contamination, so care must be exercised to reduce the sources of any particulate matter.²

Product Selection
Careful consideration must be given to the cleaning products and chemical agents employed in your compounding areas. You must take the time to think through all the parts and pieces that make up your overall cleaning program to ensure the program is effective, practical for every day activities, and does not degrade the ISO Class 7 or 8 air quality.

There are a myriad of choices in cleaning agents and their expense and actions vary greatly. Though isopropyl alcohol is widely used to clean ISO Class 5 compounding surfaces, 3% hydrogen peroxide and 2% sodium hypochlorite (bleach) are also effective as sanitizing agents.^2,3 Your protocol should include a rotation of cleaning agents to prevent development of resistant microflora.⁴ Whatever agent is chosen, it is also of paramount importance to follow the manufacturer’s recommendations with respect to the storage, handling, and dilution of the product. USP <1072> (Disinfectants and Antiseptics) is a good resource in this area.

USP <1072> includes information on both hard surface and skin sanitization techniques, both of which are important to maintaining microbial control of pharmaceutical manufacturing areas. The document states, “The cleaning and sanitization program should achieve specified cleanliness standards, control microbial contamination of products, and be designed to prevent the chemical contamination of pharmaceutical ingredients, product-contact surfaces and/or equipment, packaging materials, and ultimately the drug products.” These issues are relevant not only for aseptic areas and products, but also for non-sterile forms of product dosage.⁵

Beyond the agents used, the cleaning equipment employed must also be carefully considered. Buckets, mop handles, and mop heads should be chosen with care. Cleaning equipment should be selected for its ergonomics, durability, and construction. Sometimes the equipment with the lowest acquisition price has a considerably shorter useful life than more expensive, yet more durable products. In other words, low-priced items may end up costing more in the long run. For example, conventional cellulose sponge mop heads are relatively inexpensive, but begin to breakdown within one week and should be changed as soon as they show signs of wear, and conventional mop handles are not designed for the rigors of the cleanroom environment and rarely last more than one month. Additionally, inexpensive mop buckets designed for household systems may become too heavy when filled or may be too large to fit in your pharmacy’s sink. Therefore, they are frequently inappropriate for cleanroom cleaning applications.

Fortunately, there is a better solution. Try a stainless steel mop system, with interchangeable handles and swivel mop heads that use disposable pads or covers specifically designed for ISO Class 5 areas. Although the initial investment will be higher, the annual savings will be realized in the less frequent changing of the handles. Furthermore, this efficient system will save staff time and can improve staff morale and acceptance of your cleaning protocol. 

Likewise, the use of larger lint-free wipes, for example a 12-by-12-inch wipe, may carry a higher acquisition cost than smaller wipes, such as a 9-by-9-inch wipe, but may reduce the number of wipes used during a cleaning cycle, and could, in fact, save money. Furthermore, the use of pre-moistened wipes may seem like an extravagance, but can promote labor savings if their use assists the staff in effectively cleaning the rooms in less time. Additionally, some of these pre-moistened wipes are available with dispensers that can be operated with one hand, which may encourage better technique among your personnel.